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      Phase I/II study of concurrent chemoradiotherapy for localized nasal natural killer/T-cell lymphoma: Japan Clinical Oncology Group Study JCOG0211.

      Journal of clinical oncology : official journal of the American Society of Clinical Oncology
      Adult, Age Factors, Aged, Antineoplastic Combined Chemotherapy Protocols, Biopsy, Needle, Carboplatin, Combined Modality Therapy, Dexamethasone, Disease-Free Survival, Dose-Response Relationship, Drug, Drug Administration Schedule, Etoposide, Female, Humans, Ifosfamide, Immunohistochemistry, Japan, Kaplan-Meier Estimate, Lymphoma, Extranodal NK-T-Cell, diagnosis, drug therapy, mortality, radiotherapy, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Staging, Nose Neoplasms, pathology, Probability, Proportional Hazards Models, Radiotherapy Dosage, Radiotherapy, Adjuvant, Radiotherapy, Conformal, Risk Assessment, Sex Factors, Survival Analysis, Treatment Outcome, Young Adult

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          Abstract

          To explore a more effective treatment for localized nasal natural killer (NK)/T-cell lymphoma, we conducted a phase I/II study of concurrent chemoradiotherapy. Treatments comprised concurrent radiotherapy (50 Gy) and 3 courses of dexamethasone, etoposide, ifosfamide, and carboplatin (DeVIC). Patients with a newly diagnosed stage IE or contiguous IIE disease with cervical node involvement and a performance status (PS) of 0 to 2 were eligible for enrollment. The primary end point of the phase II portion was a 2-year overall survival in patients treated with the recommended dose. Of the 33 patients enrolled, 10 patients were enrolled in the phase I portion and a two thirds dose of DeVIC was established as the recommended dose. Twenty-seven patients (range, 21 to 68; median, 56 years) treated with the recommended dose showed the following clinical features: male:female, 17:10; stage IE, 18; stage IIE, 9; B symptoms present, 10; elevated serum lactate dehydrogenase, 5; and PS 2, 2. With a median follow-up of 32 months, the 2-year overall survival was 78% (95% CI, 57% to 89%). This compared favorably with the historical control of radiotherapy alone (45%). Of the 26 patients assessable for a response, 20 (77%) achieved a complete response, with one partial response. The overall response rate was 81%. The most common grade 3 nonhematologic toxicity was mucositis related to radiation (30%). No treatment-related deaths were observed. Concurrent chemoradiotherapy using multidrug resistance-nonrelated agents and etoposide is a safe and effective treatment for localized nasal NK/T-cell lymphoma and warrants further investigation.

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